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Procedure

Duodenal-Ileal Diversion Device for Obesity

N/A
Waitlist Available
Led By Walter Medlin, MD
Research Sponsored by GI Windows, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 22-65 years at screening
Obesity with BMI ≥ 35 kg/m2 with at least one obesity related comorbidity or ≥ 40 but ≤ 50 kg/m2 with or without comorbidities at time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new device that creates a dual-path duodenal-ileal diversion. The device will be used during sleeve gastrectomy or on patients who have had sleeve gastrectomy and need more weight loss. The trial will evaluate the weight loss and improvement of metabolic comorbidities in obese subjects.

Who is the study for?
This trial is for adults aged 22-65 with obesity (BMI ≥ 35 kg/m2 with comorbidities or BMI between 40 and ≤ 50 kg/m2). It includes those who had a sleeve gastrectomy at least 18 months ago but didn't lose enough weight. Participants must be non-smokers, live near the study center, control any related health issues like hypertension, and women must avoid pregnancy.Check my eligibility
What is being tested?
The trial tests Self Forming Magnets (SFM) to create a dual-path duodenal-ileal diversion during or after sleeve gastrectomy surgery. The goal is to see if this procedure is safe and functional for inducing weight loss and improving metabolic conditions in obese patients.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include complications from gastrointestinal surgery such as pain, infection, bleeding, or adverse reactions to anesthesia. There could also be specific risks associated with the SFM device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 22 and 65 years old.
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My BMI is 35 or higher with a related health issue, or it's between 40 and 50.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Weight Loss
Secondary outcome measures
%EWL
Hemoglobin A1c
Percent Responders
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: SNAP-SExperimental Treatment1 Intervention
Creation of a D-I diversion in participants undergoing primary sleeve gastrectomy (SNAP-S cohort)
Group II: SNAP-PSExperimental Treatment1 Intervention
Creation of a D-I diversion in participants who have experienced inadequate weight loss following sleeve gastrectomy (SNAP-PS cohort)

Find a Location

Who is running the clinical trial?

GI Windows, Inc.Lead Sponsor
7 Previous Clinical Trials
530 Total Patients Enrolled
2 Trials studying Obesity
33 Patients Enrolled for Obesity
Walter Medlin, MDPrincipal InvestigatorBariatric Medicine Institute, Salt Lake City, UT
Daniel Cottam, MDPrincipal InvestigatorBariatric Medicine Institute, Salt Lake City, UT

Media Library

Self Forming Magnets (SFM) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05064722 — N/A
Obesity Research Study Groups: SNAP-S, SNAP-PS
Obesity Clinical Trial 2023: Self Forming Magnets (SFM) Highlights & Side Effects. Trial Name: NCT05064722 — N/A
Self Forming Magnets (SFM) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05064722 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the qualification criteria for participating in this medical experiment?

"This trial is recruiting 10 participants, aged between 22 and 65 years old, who suffer from morbid obesity. Other criteria includes having a Body Mass Index (BMI) of either ≥ 35 kg/m2 with at least one related comorbidity or ≥ 40 but ≤ 50 kg/m2 without any other complications. Furthermore, if the patient has hypertension, lipid disorders or sleep apnea they must be properly managed. Patient also needs to live within 300 km of the study centre for 24 months and refrain from smoking during follow-up period."

Answered by AI

Is enrollment for this experiment still open to participants?

"The information on clinicaltrials.gov indicates that this particular trial is not open to new participants at the moment, having been posted on November 8th 2021 and last updated August 8th 2022. However, 306 other studies are currently recruiting patients for their respective trials."

Answered by AI

Are septuagenarians eligible to partake in the experiment?

"Eligible participants must be over 22 years old and under 65 to partake in this clinical trial."

Answered by AI

Who else is applying?

What site did they apply to?
Bariatric Medicine Institute
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I am severely obese. I’m waisting away life hiding in my bedroom.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Duodenal-Ileal Diversion in Obese Patients Undergoing Primary Sleeve or Those With Inadequate Weight Loss After Sleeve
2021. "Duodenal-Ileal Diversion in Obese Patients Undergoing Primary Sleeve or Those With Inadequate Weight Loss After Sleeve". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05064722.
All > Morbid Obesity
~3 spots leftby Apr 2025
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